The Senate approved the previously House-passed Taking Essential Steps for Testing Act (also known as the “TEST Act”) this week, clearing the way for President Obama’s signature and enactment. The legislation, which amends a provision of the Clinical Laboratory Improvement Amendments (CLIA), makes clear that the Centers for Medicare & Medicaid Services (CMS) has the authority to impose intermediate sanctions instead of revoking the CLIA certificate of a laboratory that has referred a proficiency testing sample to another laboratory. The TEST Act was introduced by Rep. Michael Grimm (R-NY), and it quickly gained wide bipartisan support. According to the American Clinical Laboratory Association, “[t]he bill grants [CMS] much-needed discretion so that clinical laboratories will not have their CLIA certificates revoked for the unintentional referral of proficiency testing samples to other laboratories.” The legislation also received support from the College of American Pathologists.

Karen Lovitch is the Practice Leader of the firm’s Health Law Practice. She counsels health care clients on regulatory, transactional, and operational issues, including Medicare coverage and reimbursement, the development and implementation of health care compliance programs, and licensure and certification matters. Her experience includes matters related to the anti-kickback statute, the Stark law, state statutes prohibiting kickbacks and self-referrals, and the federal Physician Payments Sunshine Act.

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Mintz Levin’s Health Law Practice

As the health care and life sciences industries continue to undergo sweeping regulatory change, your company might be facing unprecedented structural and operational challenges. Heightened government scrutiny of industry practices certainly adds to the complexity of operating in the market for all providers, payors, manufacturers, distributors, and suppliers.Read More